In order to promote monitoring and reporting of Adverse Drug Reactions (ADRs) by NABH accredited Hospitals to Pharmacovigilance Programme of India (PvPI), around 600 National Accreditation Board for Hospitals and Healthcare providers (NABH) accredited hospitals have started reporting ADRs as part of their pharmacovigilance activities mandated by the government.
This is followed by Indian Pharmacopoeia Commission (IPC) signing an Memorandum of Understanding (MoU) with NABH. IPC is the National Coordination Centre (NCC) for PvPI.
Informs Bhupendra Kumar Rana, chief executive officer Incharge, NABH, “Around 600 NABH accredited hospitals have started reporting ADRs to the NCC as part of their pharmacovigilance activities.”
Pharmacovigilance (PV) is a science that relates to detection, assessment, understanding and prevention of adverse affects or any other drug related problem. To track adverse drug reactions (ADRs) in Indian population, Union health ministry launched PvPI which has outreach all over the country but only a small portion of healthcare professionals have formal training in PV.
This will also go hand-in-hand with IPC also having started "Skill Development Programme on Basics and Regulatory Aspects of Pharmacovigilance" from January 2017 onwards. The programme aims to enhance the knowledge and skill of qualified pharmacovigilance professionals working for ensuring better patient safety as per the requirement of Schedule Y of Drug and Cosmetics Act, 1940.
Young pharmacy, medical and paramedical professionals seeking career in pharmacovigilance and existing professionals in pharmacovigilance are being taught by renowned experts from government teaching and corporate hospitals, regulatory authority, WHO, pharmaceutical industries, academic and research institutions.
The skill development initiative will encourage process of creating a registry of skills, enable and mobilize a large number of healthcare professionals to take up training and acquire requisite skills for employment apart from capacity building and strengthening of Qualified Person for Pharmacovigilance (QPPv) as per the requirement of the schedule Y of D&C Act.
In August 2016, Drug Controller General of India (DCGI) had issued a circular stipulating the deadline at January 1, 2018 for upgrading skill sets of persons employed in their units.
“Keeping in view the objective of bringing substantial improvement in the quality of pharmaceutical products, it has become imperative that all personnel employed in pharmaceutical manufacturing units shall undergo the certification programs developed by Life Science Skill Development Council (LSSSDC) and with effect from January 1, 2018, no person shall be employed in any pharmaceutical, bio-pharmaceutical manufacturing units unless he has obtained a formal degree in the relevant area, or has been certified by LSSSDC or equivalent organization in the area in which he has been deployed,” the DCGI circular then said.